Recall MonitorHealth Products
Osstell® Smartpeg Type 101-104
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Dental
Product: Osstell® Smartpeg Type 101-104
Issue: Medical devices - Performance
What to do: Contact the manufacturer Osstell has a new IFU under implementation and has initiated a design change.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Osstell® Smartpeg Type 101-104 | Not applicable. | 100766 |
| Osstell® Smartpeg Type 101-104 | Not applicable. | 100767 |
| Osstell® Smartpeg Type 101-104 | Not applicable. | 100769 |
| Osstell® Smartpeg Type 101-104 | Not applicable. | 100768 |
Issue
If not correctly used with a reference measurement on implant level. The measurement on abutment can indicate a false high ISQ value. This can influence the clinician to take the wrong decision and load the implant too early, in the extension potentially resulting in implant failure for the patient. Recall start date: May 23, 2025